The Rundown: ExL’s Blog

Viewing 1 to 10 of 103 records.

It is a distinguished privilege to chair ExL Events’ Pharmacovigilance Audit and Inspections Conference on March 26–27 in Philadelphia. As the conference chairperson, I am eager to welcome you to this benchmark event.

It is my mission to ensure this program equips attendees with skills and practices to adapt and continue to lead the way in complying with global regulations and replicating effective practices in drug safety.

I look forward to learning what lies in store for our work; from new technologies, artificial intelligence, new regulations, and innovative approaches, to ensuring quality and compliance during audits and inspections. To view the full program,

A successful disease awareness campaign will either resonate with patients about the burden of their disease or improve the way HCP educate and engage with their patients around a disease state. Educational and impactful messaging for a successful campaign requires a deep understanding of the patient’s journey and knowledge gaps about a particular disease state.

The Disease Awareness Campaigns Forum, April 4–5, in Philadelphia, will be two days for marketing, communications, and patient/HCP engagement professionals to discuss strategies for building better disease education campaigns. Here are some of the strategies the…

Check out a great article by Applied Clinical Trials, interviewing Kevin Hudziak following his recent presentation at ExL Events’ CROWN on Eli Lilly’s patient engagement initiatives. The interview was conducted by a previous CROWN presenter, Moe Alsumidaie, too!

When asked to explain changing patient behaviors, Husziak said, “Patients and patient communities/advocates are becoming empowered to take a more active role in healthcare, and the digital world is altering the way that people seek healthcare information. Patients are also self-identifying for clinical trials.”

An average clinical trial can cost $60–80 million. Adaptive design allows a sponsor to modify multiple parts of a trial without incurring additional costs. Using this innovative method will present the opportunity to stipulate collected data at various intervals in order to adjust one or more detailed aspects of the study based on analysis of the data. It is proven that this approach will allow a trial to more efficiently demonstrate the effects of a drug.

Take an in-depth look at how Cytel assisted Napo Pharmaceuticals to optimize an adaptive speed and control to achieve orphan drug exclusivity protection. This…

The Central Monitoring Summit, scheduled for March 22–23 in Philadelphia, has an outstanding list of expert presenters who will deal with the complex issues we must face while exploring the challenges, impacts, and implications of risk-based monitoring. Subjects such as the updated ICH E6 (R2) Guidelines, implementing central monitoring, and the shifting role of a CRA are just some of the topics to be addressed during this meeting. This conference presents an opportunity to examine the present status and future direction of RBM and central monitoring. You can view the full agenda here.

Frequently, new formulation approaches end up disappointing the industry because, instead of a breakthrough, they yield slow, incremental development. Is there anything on the horizon that can truly accelerate your drug pipeline? As The Washington Post reports, just a few weeks ago, FDA announced a pilot program to release more detailed study reports from clinical trials. This initiative should quickly provide drug development teams with a much larger library of information about safety and efficacy results to guide their own R&D. How is your company going to take advantage of this new program? Will the drugs you are working…

As the conference chair for MASS East 2018, I would like to invite you to join us in New Brunswick, NJ, on April 9–11 for this innovative and collaborative event. This forum is the ideal meeting place for you and your team members to exchange strategic and operational insights with your industry peers and hear how to optimize the overall quality and effectiveness of your medical operations.

This year’s program hosts a diverse speaking faculty of industry leaders responsible for medical affairs, field activities and Investigator-Initiated Trials. They will offer thought-provoking discussions and actionable solutions for managing medical affairs…

Our friends over at Applied Clinical Trials Online recently shared updates gleaned from attending ExL Events’ January 2018 CROWN Congress with their audience. This article exemplifies the benefits of attending an ExL conference and we thank the publication for sharing this information.

Applied Clinical Trials shared highlights from the Congress, including the following sessions:

Below, you’ll find an excerpt from a recent article featured in the February issue of PM360, praising ExL’s November 2017 event, the Value-Based Strategies for Reimbursement & Formulary Success conference.

The conference focused on market access and payer policies, and speakers from a number of industry giants addressed such issues as the importance of differentiating a product’s value from its therapeutic value; decreasing overall healthcare costs; proactive strategies that expand market access; and solving for the complexities HCPs face that delay patient therapy—especially in the oncology health model. Both public and private…

You might not have an inspection in two weeks, but if you did, are you prepared? ExL Events’ 4th Clinical Trial Inspection Readiness Summit is in three months, and our expert speaking faculty will help ensure you and your teams are prepared for your next inspection.

At this annual event, you will explore detailed examinations of how to handle an actual inspection, discover how to integrate technology validation into inspection readiness procedures, learn to implement the requirements of ICH E6 R2 within trial management and other related systems, select a vendor that matches the sponsor’s culture, discuss case studies,…

Featured Partners

Kelly Willenberg LLC is a full service research compliance organization serving clients on improving operations. She employs technologies to improve operational aspects of compliance based on client needs. She assists in the implementation of billing compliance programs, offers training seminars, builds coverage analysis and helps with process improvement. She can also assist with process improvement, quality assurance and assessing vulnerabilities in all aspects of research compliance.Read more.

FiercePharma is a digital media publication, reporting and delivering daily news and objective analysis for business professionals in global industries. FiercePharma offers broad coverage serving a wide range of specific functional interests, including manufacturing regulation, financial management, quality control and production methods; shareholder pressure and speed-to-market strategies; sales and marketing access to physicians and navigating payer rules; the impact of pricing and partnerships on the pipeline; and the influence of big data, executive moves and social media on it all.

Latest Blog Post

Message From the Pharmacovigilance Audit and Inspections Conference Chair

It is a distinguished privilege to chair ExL Events’ Pharmacovigilance Audit and Inspections Conference on March 26–27 in Philadelphia. As the conference chairperson, I am eager to welcome you to this benchmark event.

Connect With Us

In addition to conferences, ExL Events also provides industry-related content through a variety of social platforms. Be sure to follow the profiles that fit your topics of interest to gain access to the latest content and industry news.